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Brief Title: To Assess Efficacy and Safety of Oral Reparixin in Patients With Fatigue and Locally Advanced / Metastatic Breast Cancer
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Assess Efficacy and Safety of Reparixin in Cancer Related Fatigue in Pts With Advanced / Metastatic Breast Cancer Undergoing Taxane-based Chemotherapy.
Study ID: NCT05212701
Brief Summary: Primary objective: • To assess the efficacy of reparixin compared to placebo in limiting CRF in adult patients with locally advanced or metastatic breast cancer undergoing single-agent taxane chemotherapy, using FACITFatigue scale. The secondary objectives are: * To evaluate change in Quality of Life in the two treatment arms * To assess the percentage of patients treated with reparixin compared to placebo delaying and discontinuing chemotherapy * To assess Patient Global Impression of Severity (PGI-S) score and Patient Global Impression of Change (PGI-C) score associated with reparixin compared to placebo * To assess the effect of reparixin compared to placebo on ECOG PS * To assess the effects of reparixin vs placebo on Objective Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS) The safety objective is: • To assess the safety and tolerability of reparixin in adult patients undergoing taxane-containing chemotherapy. The pharmacokinetic (PK) objective is: • To define the PK profile of orally administered reparixin, its metabolites (DF2243Y, DF2188Y, ibuprofen) and concomitant antineoplastic agents (paclitaxel, or nab-paclitaxel or docetaxel) in adult patients with locally advanced or metastatic breast cancer.
Detailed Description: This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled study. It will evenly randomize 68 evaluable men and women adult patients with CRF in locally advanced or metastatic breast cancer who are candidates to start single-agent taxane chemotherapy (paclitaxel, nab-paclitaxel or docetaxel). CRF will be assessed at baseline on a scale from 0 - 10 (with 10 being most severe), enrolling any patient who report a score of 1 - 6. Recruitment will be competitive among the study sites, until the planned number of patients is randomized. Patients will be assigned (1:1) to receive either oral reparixin treatment (1200 mg t.i.d. - treatment group) or masked placebo t.i.d. (control group). Randomization will be stratified by site and according to the type of chemotherapy (paclitaxel vs docetaxel vs nab-paclitaxel). Sparse blood samples will be collected in the whole population for reparixin (and metabolites), docetaxel, nab-paclitaxel, paclitaxel PK analysis. Reparixin or placebo will be administered for 16 weeks or until disease progression, withdrawal of consent or unacceptable toxicity, whichever occurs first. Following the completion of the treatment, or after premature discontinuation during the double-blind phase the patients will be followed up for safety assessments for an additional 30 days after last study therapy administration and will be followed for progressive disease and survival until twelve months after last enrolled subject off treatment, or until trial is terminated for other reasons, whatever occurs first. Number of Patients Sixty-eight (68) evaluable adult patients with CRF with locally advanced or metastatic breast cancer who are candidates to receive single-agent taxane chemotherapy will be included in the study. Assuming that 10% of subjects will not be evaluable for primary analysis, a total of approximately 76 subjects is expected to be enrolled.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Waverly Hematology, Cary, North Carolina, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Kliniken Essen-Mitte, Klinik für Senologie/ Interdisziplinäres Brustzentrum, Essen, , Germany
Praxis für Interdisziplinäre Onkologie & Hämatologie, Freiburg, , Germany
Mammazentrum Hamburg am Krankenhaus Jerusalem, Hamburg, , Germany
Klinikum Ernst von Bergmann, Frauenklinik, Potsdam, , Germany
IRCCS Oncologico Istituto Tumori Giovanni Paolo II, Bari, , Italy
Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi, Bologna, , Italy
ASST-Spedali Civili di Brescia, Brescia, , Italy
E.O. Ospedali Galliera, Genova, , Italy
Istituto Scientifico Romagnolo per lo Studio e La Cura dei Tumori SRL IRCCS, Meldola (FC), , Italy
IRCCS - Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliera di Perugia, Ospedale Santa Maria della Misericordia, Perugia, , Italy
Azienda Ospedaliera Universitaria Pisana, Pisa, , Italy
"Azienda Unità Sanitaria Locale della Romagna Ospedale Infermi di Rimini", Rimini, , Italy
Istituti Fisioterapici Ospitalieri- IFO - Istituto Regina Elena, Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Roma, , Italy
"Azienda Ospedaliero Universitaria Sant'Andrea ", Roma, , Italy
Ospedale Giuseppe Mazzini di Teramo, Teramo, , Italy
A.O. "Pia Fondazione Cardinale Panico", Tricase, , Italy
Name: Enrico Minnella, MD
Affiliation: Dompé Farmaceutici S.p.A
Role: STUDY_DIRECTOR